The Women's Health Initiative (WHI) is a randomized controlled trial evaluating the risks and benefits of combination hormone replacement therapy (HRT -- Estrogen plus Progestin) in healthy postmenopausal women. It was published in the 17 July 2002 edition of the Journal of the American Medical Association, and has been widely reported in the media.
The study included over 16,000 women in menopause who had not had a hysterectomy, and they participated in the study for an average of 5.2 years. The results showed that for every 10,000 women who took HRT instead of no hormones for 1 year, an additional 8 developed invasive breast cancer, 7 had a heart attack, 8 had a stroke, 8 had a PE, 6 avoid colon cancer, and 5 avoid a hip fracture. Over the duration of the 5.2 year trial, HRT caused 1 additional adverse event per 100 women compared to taking placebo.
The WHI study demonstrated that HRT does not provide protection against heart disease; in fact, it increases the risk of cardiovascular disease (37 vs 30 cardiovascular events per 10,000 person-years).
The WHI study found a significant decrease in osteoporosis bone fractures in healthy women as a result of hormone treatment (5 fewer hip fractures per 10,000 person-years). This benefit needs to be weighed against the risks of therapy.
So far, these findings are limited to combination HRT: The trial evaluating estrogen alone in women who have had a hysterectomy is continuing as the risk/benefit ratio for estrogen alone is not yet clear.
Questions:
What if I am taking hormone replacement therapy for symptoms of menopause (hot flashes, mood changes, night sweats)? The risk of adverse effects with short-term use of hormone replacement therapy is low. Many women find that the benefit in reducing symptoms is dramatic and outweighs the potential side effects.
What if I am taking estrogen alone because I have had a hysterectomy? The recently published study results do not apply to you. The WHI study has not found the same breast cancer risk for women who are taking estrogen alone. (Progestin is prescribed to women to help prevent cancer of the uterus.) We do not advise you to stop your medication. There will be more information from the WHI study over the next several years.
What if I am taking hormone replacement therapy to prevent osteoporosis? You need to weigh the potential benefits and risks of therapy. This decision is not an urgent one and should be made thoughtfully. If you have any questions about your particular medication situation, please call your doctor or nurse-practitioner or plan to discuss it at your next appointment. All women can decrease their risk for hip and other fractures by consuming adequate calcium and Vitamin D - either in your diet or with supplements, and by getting regular exercise.
What should I do if my doctor encouraged me to take hormones to help prevent heart disease? Heart disease remains the number one cause of death for postmenopausal women in this country. This study showed that estrogen combined with progesterone did not help to prevent heart disease. Women who are taking hormones primarily to prevent future heart attacks or strokes should stop taking hormones. This decision is not urgent. It is OK to stop them on your own, but if you have questions about your particular medication situation, discuss them with your health care provider.
What if I am taking the estrogen patch or estrogen cream? The WHI study did not address either of these issues. The estrogen patch, when used in conjunction with progesterone, may also increase the risk of breast cancer, strokes, and heart attacks, but we do not know at this point. Estrogen vaginal cream is most likely a safe way to treat menopausal symptoms of vaginal dryness because only a small amount of the hormone is absorbed into the blood stream.
Although all medications have risks, HRT remains a safe and effective treatment for the "vasomotor symptoms" of menopause. The absolute risk associated with short-term HRT is low.
If you have any questions about your medications and whether you should continue taking them, please contact your doctor. If you are concerned, there is no harm in stopping your therapy, or in restarting at a later time.
Non-hormone treatment for Menopause symptoms
BOTANICAL MEDICINES*: all doses are 3 times per day (Unless otherwise noted).
Black cohash (Cimicifuga racemosa) - Powdered rhizome: 1-2 g, or Tincture (1:5): 4 -6 ml, or Fluid extract: (1:1): 3-4 ml (1 tsp), or Solid (dry powdered ) extract (4:1): 250-500 mg. Available as "Remifemin" 20mg.
Chasteberry (Vitex agnus-castus) - powdered berries or as tea: 1-2 g, or Fluid extract: (1:1 ): 4 ml (1 tsp), or Solid dry powder extract (4:1): 250-500 mg.
Dong quai (Angelica sinensis) - powdered root or as tea: 1-2 g, or Tincture (1:5): 4 ml (1 tsp), or Fluid extract: 1 ml (1/4 tsp).
Ginko biloba extract (24% ginko flavoglycoside content): 40 MG.
Licorice (Glycyrrhiza glabra) - Powdered root or tea: 1-2 g, or Fluid extract: (1:1 ): 4 ml (1 tsp), or Solid dry powder extract (4:1): 250-500 mg.
Vitamin E: 800 IU per day until symptoms have improved, then 400 IU per day.
BONE HEALTH - 1500 mg of calcium a day, total from all sources, get weight bearing exercise, monitor your height, and get a bone density test if there is a sudden change. Don't smoke or drink frequent carbonated beverages.
CARDIOVASCULAR HEALTH - don't smoke, get physical exercise, eat a diet low in animal fat and simple carbohydrates, high in healthy fat (fish, olive oil, nuts) and whole grain foods.
SOY - The consumption of soy has been found to significantly reduce the incidence of hot flushes. In a recent double-blind, placebo-controlled study, hot flushes were reduced by 45 percent in the women who received 60 g of soy protein isolate daily (isoflavone content was not standardized). This reduction was significantly greater than in the subjects who received placebo, although the placebo group also experienced a 30 percent reduction in hot flushes.
The U.S. Food and Drug Administration has recently allowed labeling of soy-rich foods as "capable of decreasing the risk of heart disease." This claim is based on the well-documented lipid lowering effects of soy. One meta-analysis showed a 9 percent decrease in total cholesterol levels and a 13 percent decrease in low-density lipoprotein (LDL) levels in patients taking 50 g of soy per day. The role of soy in preventing cardiovascular disease specifically in postmenopausal women has yet to be studied. Long-term studies need to be undertaken to determine if this observed lipid-lowering effect translates into a decreased incidence of cardiovascular events and cardiovascular mortality in postmenopausal women. +
*Encyclopedia of Natural Medicine, Rev. 2nd Edition, Michael Murray, ND and Joseph Pizzorno, ND, pp 243-644.
+ American Family Physician, Alternative Therapies for Traditional Disease States: Menopause, Vincent Morelli, M.D., and Christopher Naquin, M.D. July 1, 2002